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Radiation Therapy

Hypo-fractionated vs Standard IMRT with Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Krishna Reddy, MD, PhD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females age ≥ 18 years

Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC)

Must not have

Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study

Has a known allergic reaction to any excipient contained in the study drug formulations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment for up to 7.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new radiation treatment plan, combined with two cancer drugs and an immunotherapy drug, can help improve cancer control in the body compared to the standard radiation treatment plan.

Who is the study for?

Adults diagnosed with Stage IIIA or IIIB non-small cell lung cancer (NSCLC) who have no brain metastases, negative PET/CT for distant metastasis, and adequate organ function. Women must not be pregnant and agree to contraception. Excluded are those with severe diseases, other treatments, infections, prior thoracic radiotherapy or certain psychiatric/social situations.

What is being tested?

The trial is testing if a shorter course of high-dose radiation therapy (hypo-fractionated IMRT) combined with chemotherapy and immunotherapy improves local control of lung cancer compared to the standard longer course (standard-fractionated IMRT), followed by maintenance durvalumab.

What are the potential side effects?

Possible side effects include reactions related to radiation such as skin irritation and fatigue; chemotherapy-related issues like nausea, hair loss; immunotherapy may cause immune system-related inflammation affecting various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My lung cancer is at stage IIIA or IIIB.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not using, nor plan to use other cancer treatments while in this study.

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I am allergic to ingredients in the study medication.

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I have been diagnosed with HIV/AIDS.

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I have an active connective tissue disorder like lupus or scleroderma.

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I have had radiation therapy to the chest area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment for up to 7.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment for up to 7.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment for up to 7.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Locoregional control (LRC)

Secondary study objectives

Acute toxicities

Late toxicities

Measuring the Impact of Treatment on the Quality of life (QOL)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hypo-FractionationExperimental Treatment1 Intervention

Participants will receive one fraction of radiation therapy a day for 5 days each week for 5 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin area under the curve (AUC) 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months.

Group II: Standard-FractionationActive Control1 Intervention

Participants will receive one fraction of radiation therapy a day for 5 days each week for 6 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin AUC 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months.

0 / 8Eligibility criteria met